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Longeveron

Longeveron, Inc. is a clinical stage biotechnology company. It engages in the development of cellular therapies for specific aging-related and life-threatening conditions. Its lead product, LOMECEL-B, is a cell-based therapy product, which is derived from culture-expanded medicinal signaling cells that are sourced from bone marrow of young, healthy, adult donors. The company was founded by Joshua M. Hare and Donald M. Soffers on October 9, 2014 and is headquartered in Miami, FL.

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Longeveron reports promising Q1 results, secures funding for growth

Longeveron's Q1 2024 earnings call highlighted positive Phase I results for HLHS and cost management efforts. The company secured funding for further development and welcomed new board members. Challenges include regulatory hurdles and market competition, but opportunities lie in expanding therapeutic applications and revenue growth potential.

Longeveron reports positive Q2 results, eyes contract services expansion

Longeveron's Q2 2024 earnings call highlighted strong performance in trials and financials, with a focus on HLHS program advancement and contract services expansion. The company faces challenges in addressing analyst inquiries and maximizing its contract services business potential, but has opportunities for revenue growth and leveraging positive trial outcomes.

Longeveron reports robust revenue growth and progresses towards FDA approval

Longeveron's Q3 2024 performance reflects strong revenue growth and advancements in regulatory pathways for their product candidate, Lomecel-B, across multiple therapeutic areas.
The company's focus on cellular therapies aligns with a lucrative market potential in the U.S., but funding needs for accelerated activities and competitive challenges pose considerations for future strategies.

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Longeveron, Inc. is a clinical stage biotechnology company, which engages in the development of cellular therapies for specific aging-related and life-threatening conditions. Its lead product, LOMECEL-B, is a cell-based therapy product, which is derived from culture-expanded medicinal signaling cells that are sourced from bone marrow of young, healthy, adult donors. The company was founded by Joshua M. Hare and Donald M. Soffer on October 9, 2014 and is headquartered in Miami, FL.

Longeveron, Inc. (NASDAQ:LGVN ) Q3 2024 Earnings Conference Call November 12, 2024 4:30 PM ET Company Participants Derek Cole - IR, Advisory Solutions Wa'el Hashad - CEO Nataliya Agafonova - CMO Lisa Locklear - CFO Joshua Hare - Co-Founder, Chief Science Officer & Chairman Conference Call Participants Boobalan Pachaiyappan - ROTH Capital Partners Operator Ladies and gentlemen, greetings and welcome to the Longeveron Third Quarter 2024 Earnings Call. At this time, all participants are in a listen-only mode.

Longeveron, Inc. (LGVN) Q3 2024 Earnings Call Transcript

Longeveron has appointed Devin Blass as Chief Technology Officer (CTO) and SVP of CMC, effective Dec 2, adding capabilities ahead of potential BLA filing.

Longeveron® Appoints Devin Blass as Chief Technology Officer and SVP of Chemistry, Manufacturing and Controls (CMC)

Longveron will report third quarter 2024 financial results and provide a business update on Tuesday, November 12th after the U.S. financial markets close.

Longeveron® to Report Third Quarter 2024 Financial Results and Host Conference Call on November 12, 2024

Findings offer potential mechanistic and clinical insights in the development of cellular therapy Lomecel-B™ for mild Alzheimer's disease (AD) Lomecel-B™  capacity to inhibit MMP14 correlates with improved clinical and biomarker outcomes in mild AD Immunomodulatory and pro-vascular effects of Lomecel-B™  in mild AD potentially driven by ability to exert MMP14 inhibition which may protect TIE2 receptor integrity in human AD patients MIAMI, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that its submission entitled “Lomecel-B inhibition of MMP14 activity predicts Lomecel-B bioactivity in the treatment of mild Alzheimer's disease” was presented as a late breaking poster presentation at the 17th edition of the Clinical Trials on Alzheimer's Disease Conference (CTAD24) taking place October 29 -November 1, 2024 in Madrid, Spain. “As a medicinal signaling cell therapy that has multiple potential mechanisms of action to address inflammatory responses in the brain, Lomecel-B™ offers the potential to address the underlying pathology of Alzheimer's disease,” said Joshua Hare, M.D.

Longeveron® Presents Lomecel-B™ Data for Alzheimer's Disease Indication in Late Breaking Poster Presentation at the Clinical Trials on Alzheimer's Disease Conference (CTAD24)

Oral presentation highlights findings that patients treated with Lomecel-B TM in ELPIS I, in an open-label follow-on study, experienced 5-year survival after stage 2 Glenn surgery of 100% with none requiring heart transplant; this compared to the largest data set from the Single Ventricle Reconstruction Trial which showed 83% survival, with a 5.2% heart transplantation rate ELPIS I met its primary endpoint of safety through 1-year post-treatment, with 100% survival rate, 100% transplant-free and patients maintained expected rate of growth one year after treatment Findings support cell based therapy as a potential adjunct to HLHS reconstruction surgery to improve clinical benefits and reduce the need for subsequent heart transplantation ELPIS II Phase 2b clinical trial is currently ongoing, further evaluating Lomecel-B TM as a potential adjunct therapy for HLHS versus standard of care alone MIAMI, Oct. 27, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that its positive long-term transplant-free survival data from a multi-year follow-on study to the ELPIS I Phase 1 clinical trial were featured in an oral presentation at the Congenital Heart Surgeons' Society (CHSS) 51st Annual Meeting taking place October 27-28, 2024 in Chicago, Illinois. “HLHS is a devastating disease for patients and their families, so I am impressed and very encouraged to see the continued long-term survival of patients treated with Lomecel-BTM in the ELPIS I study,” said Sunjay Kaushal, M.D.

Longeveron® Presents Lomecel-B™ Long-term Transplant-free Survival Data in Hypoplastic Left Heart Syndrome (HLHS) at the Congenital Heart Surgeons' Society (CHSS) 51st Annual Meeting

Longeveron Lomecel-B data in Alzheimer's disease selected for late breaking poster presentation at Clinical Trials on Alzheimer's Disease Conf (CTAD24).

Longeveron® Lomecel-B™ Data in Alzheimer's Disease Selected for Late Breaking Poster Presentation at the Clinical Trials on Alzheimer's Disease Conference (CTAD24)

Longeveron® Lomecel-B 5-Year Long-term Transplant-free Survival Data in HLHS Selected for Oral Presentation at the Congenital Heart Surgeons' Society Mtg.

Longeveron® Lomecel-B™ 5-Year Long-term Transplant-free Survival Data in HLHS Selected for Oral Presentation at the Congenital Heart Surgeons' Society (CHSS) 51st Annual Meeting

Wa'el Hashad, Chief Executive Officer of Longeveron, will participate in a Fireside Chat at the UBS Virtual Organ Restoration and Cell Therapy Day Oct 15th

Longeveron® to Present at the UBS Virtual Organ Restoration and Cell Therapy Day

Longeveron management to present at the ROTH Healthcare Opportunities Conference. Speaking on Emerging Frontiers in Neuroscience panel and hosting 1x1s.

Longeveron® to Participate in the 3rd Annual ROTH Healthcare Opportunities Conference

Longeveron to attend Cell & Gene Meeting on the Mesa to highlight its cellular therapy program in Alzheimer's disease and CDMO facilities and services.

Longeveron to Attend Alliance for Regenerative Medicine's Cell & Gene Meeting on the Mesa

MIAMI, Aug. 26, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that it will participate in the H.C. Wainwright 26th Annual Global Investment Conference taking place September 9-11, 2024 in New York City.

Longeveron to Present at the H.C. Wainwright 26th Annual Global Investment Conference

Longeveron, Inc. (NASDAQ:LGVN ) Q2 2024 Earnings Conference Call August 14, 2024 4:30 PM ET Company Participants Derek Cole - IR, Advisory Solutions Wa'el Hashad - CEO Nataliya Agafonova - CMO Lisa Locklear - CFO Joshua Hare - Co-Founder, Chief Science Officer & Chairman Conference Call Participants Ram Selvaraju - H.C. Wainwright Operator Good day, and welcome to Longeveron's 2024 Second Quarter Financial Results Conference Call.

Longeveron, Inc. (LGVN) Q2 2024 Earnings Call Transcript

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Longeveron (NASDAQ: LGVN ) jumped after publishing a press release stating that Phase 2a results for its Alzheimer's treatment met primary endpoints. Lomecel-B is a treatment for mild cases of Alzheimer's disease.

Longeveron (LGVN) Stock Pops on Phase 2 Trial Updates

Longeveron Phase 2a clinical results in Alzheimer's Disease selected for Featured Research oral presentation at Alzheimer's Association International Conf

Longeveron® Presents Study Results from CLEAR MIND Phase 2a Clinical Trial of Lomecel-B™ in Mild Alzheimer's Disease at the Alzheimer's Association International Conference® (AAIC)

MIAMI, July 19, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or the “Company”), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules, for the issuance and sale of an aggregate of 2,236,026 shares of its Class A common stock (or common stock equivalents in lieu thereof) at a purchase price of $4.025 per share of Class A common stock (or per common stock equivalent in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, the Company issued unregistered warrants to purchase up to an aggregate of 2,236,026 shares of Class A common stock.

Longeveron Announces Closing of $9.0 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

MIAMI, July 18, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or the “Company”), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that it has entered into definitive agreements for the issuance and sale of an aggregate of 2,236,026 shares of its Class A common stock (or common stock equivalents in lieu thereof) at a purchase price of $4.025 per share of Class A common stock (or per common stock equivalent in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, the Company has also agreed to issue and sell unregistered warrants to purchase up to an aggregate of 2,236,026 shares of Class A common stock.

Longeveron Announces $9.0 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

Longeveron (NASDAQ: LGVN ) stock is rocketing higher on Wednesday after the clinical-stage biotechnology company received fast-track designation for its mild Alzheimer's Disease treatment. This has the Food and Drug Administration (FDA) granting this designation to Lomecel-B.

LGVN Stock Alert: Longeveron Pops 18% on FDA Fast-Track Designation

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Longeveron Inc (NASDAQ: LGVN) soared 100% on Wednesday after its Lomecel-B received RMAT designation from the Food & Drug Administration.  Lomecel-B is the company's investigational treatment for Alzheimer's disease.

Longeveron stock opened 100% up on Wednesday: explore why

Longeveron (NASDAQ: LGVN ) stock is rocketing higher on Wednesday after the clinical-stage biotechnology company announced a new designation from the Food and Drug Administration (FDA). This has the FDA granting Longeveron's Lomecel-B the Regenerative Medicine Advanced Therapy (RMAT) designation.

Why Is Longeveron (LGVN) Stock Up 53% Today?

Longeveron® Announces U.S. FDA Grants Lomecel-B(TM) Regenerative Medicine Advanced Therapy (RMAT) Designation for the Treatment of Mild Alzheimer's Disease

Longeveron® Announces U.S. FDA Grants Lomecel-B™ Regenerative Medicine Advanced Therapy (RMAT) Designation for the Treatment of Mild Alzheimer's Disease

MIAMI, July 09, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, including hypoplastic left heart syndrome (HLHS) and Alzheimer's disease, today announced that Neha Motwani, a senior healthcare investment banker, has been elected to the Longeveron Board of Directors at the Company's recent Annual Meeting of Stockholders. “I am delighted to welcome Neha, with her tremendous healthcare industry experience, to the Board of Directors,” said Joshua Hare, Co-founder, Chief Science Officer and Chairman of the Board at Longeveron.

Neha Motwani Elected to Longeveron® Board of Directors

Gene therapy pioneer Dr. Roger Hajjar elected to Longeveron Board of Directors as company advances it novel cellular therapy across multiple indications.

Gene Therapy Pioneer Roger Hajjar, MD, Elected to Longeveron® Board of Directors

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